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Due to the critical nature of medical devices, there are strict FDA regulatory requirements regarding validation, which requires to be adhered to across all phases of the product lifecycle from Research & Development, Manufacturing, Logistics and Release for the end customer use. Regardless of the imposed regulatory requirements, a product developer and manufacturer will want to ensure that any devices sold on the markets, achieves the highest quality, reliability standards, performs as intended and meets the expectation of the medical staff or patients.
Regardless of which phase of the product lifecycle you’re in, ValiTech can work with you to mitigate your technical and financial risks and ensure you remain compliant.
Our specialists demonstrate high standard and quality through:
Talk to us today to take advantage of our wide range of professional services.
ValiTech understands that introducing and launching new medical devices and industrial IoT to the market involves several complex activities and tasks that are critically linked to each other. From the initial conceptual design review, our focus is to add value to your development project. We bring the latest ideas, cutting edge technologies and more than 20 years of industry experience to your project.
Our experienced engineers provide a complete end-to-end solution that includes the following activities:
With the detailed technical support, proactive supply chain planning of the BOM’s components, established partnerships with a leading contract manufactures, regulatory and QC control, we are committed to developing your first fully functionin
Pilot manufacturing is a critical step in full-scale of Medical and Industrial IoT device manufacturing. If your device is successful in pilot or clinical trials, it will likely transition to volume production. ValiTech engineers will support your project during entire process to avoid any flaws in the pilot manufacturing phase and to avoid a redesign or even rework of pilot batch. Therefore, you need to find an experienced technical consultant that will work on your behalf with a device manufacturing company to ensure compliance with SOPs, specs and the overall integrity of this process.
Pilot manufacturing is the process where medical devices and industrial IoT get tested in clinical trials before transitioning to volume manufacturing. During the pilot manufacturing process, our engineers will work closely with selected contract manufactures to elaborate product design, QA processes and iteratively implement all necessary changes before volume production, where design changes may become too costly and significantly delay your project. The pilot process includes: product design, process FMEA, plastic part design, material selection, design transfer to manufacturing, rapid prototyping, DHF, DMR, DHR, validation and verification (assembly, testing, tooling and fixtures, equipment validations, packaging, sterilization, accelerated age studies and transit testing).
Successful scaling to high volume manufacturing of medical and industrial IoT devices requires foresight and planning to streamline the production process and minimize changes that can delay transfer to high-volume manufacturing, making them more lengthy and expensive.
High-volume manufacturing typically involves the introduction of cutting-edge production equipment and custom-made fixtures into the device fabrication and assembly process. High-Volume manufacturing requires a product life-cycle approach that looks beyond immediate needs and anticipates future market demand. After long-term manufacturing volume parameters have been established to complement product specifications, ValiTech skilled project managers can determine how to adequately meet both short-term and long-term volumes and create a roadmap to scale and realize the benefits of high-volume manufacturing for your project. The more we work on planning the long-term project expectations and objectives, the better and faster our contract manufacturers will be able to produce and supply devices that will meet design intent and comply with product’s intended life cycle.
Establishing a well-managed supply chain is essential in every industry. Visibility into emerging product’s supply chain is a crucial tool for controlling costs throughout the company. In order to avoid inventory shortage that can result in severe repercussions for patients, medical and some Industrial IoT devices companies carry out high levels of inventory and are notorious for having low turnover. This strategy results in high costs of maintaining too much extra product, and loss of sales representative productivity from having to manage their “over-stock.”
To get around the increased costs and risk associated with the high-inventory approach, medical device companies are elaborating multiple supply chains and pursuing operational – efficiency opportunities to guarantee cost reduction.
Selected Medical Devices and Industrial IoT contract manufacturers are implementing solutions that offer real-time visibility into on-hand inventory, production schedules and order commitments. Demand and supply chain planning solutions that provide accurate forecasts and enhanced mobile capabilities allow for significant reductions in inventory while maintaining end customer service metrics to meet commitments.
ValiTech’s supply chain specialists work closely with our customers to thoroughly plan all the stages of supply chain medical devices and optimize processes and costs. We also work with Tier 1 contract manufacturers and Logistics companies who are audited by ValiTech as well as Certified ISO 9001 and ISO 13485.
We build trust with customers based on results of cost effective supply chain solutions by close managing and controlling all phases of the supply chain (procurement, manufacturing and logistics processes) while remaining compliant with global GMP regulations.
Project execution within the Medical and Industrial sectors requires sound experience as well as deep insights into existing laws and standards. Our vast experience in various projects allows us to identify and mitigate potential delays, remove bottlenecks in the process and perform the proper risk management to keep your projects on track, within your budget and be successful. When we manage your projects, our team of industry experts see themselves as part of your company and strive to accomplish your goals, both technically and business-wise.
Several key factors determines the success of every project, some of which are listed below:
Our experienced Project Managers working on multiple activities during the planning and execution of the project will cater to:
We develop end-to-end IoT , M2M solutions and handle an entire process from a start to the finish. Our R&D department has successfully delivered planned projects for multiple years, and adhere with ISO9001, ISO13485 guidelines.